A Clinical Study of 6MW3211 in Patients With Renal Cancer

August 14, 2022 updated by: Mabwell (Shanghai) Bioscience Co., Ltd.

A Phase 2, Multicenter, Open-Label Study to Evaluate the Preliminary Efficacy and Safety of 6MW3211 in Patients With Advanced Clear Cell Renal Cancer

single arm, non-randomized, multicenter, open label, phase 2 clinical trial in patients with advanced clear cell renal cacer

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a single arm, non-randomized, multicenter, open label, phase 2 clinical trial to evaluate preliminary efficacy and safety in patients with advanced clear cell renal cacer

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Voluntarily participate in the study and sign the informed consent.
  • Advanced clear cell renal cancer.
  • At least one measurable tumor target lesion.
  • Life expectancy≥3 months.
  • Suitable organ functions.
  • Patients who had failed at least one line therapy.
  • ECOG 0-1.
  • The samples of tumor tissue should be provided

Exclusion Criteria:

  • Patients who had received anti-tumor therapy/radiotherapy/immunotherapy within 4 weeks.
  • History of other malignant tumors within 5 years.
  • Patients with CNS metastasis.
  • History of active autoimmune diseases.
  • Patients with poor-controlled systemic diseases after treatment.
  • Patients with severe infection or requiring antibiotic treatment within 4 weeks before dosing.
  • Adverse reactions related to previous treatments failed to recover to CTCAE 5.0 ≤1
  • Patients who had experienced immune-related adverse events (irAE) with grade 3 or above.
  • Patients who were allergic to any composition of experimental drug.
  • Subjects with poor treatment compliance.
  • Pregnant or lactating woman.
  • Live vaccination within 28 days before first dosing.
  • History of drug abuse or addiction
  • Patients with active HBV or HCV, or HIV antibody positive,or Tp-Ab positive.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 6MW3211
6MW3211 injection, 30mg/kg
Drug: 6MW3211
6MW3211 injection, 30mg/kg, Q2W
Other Names:
  • 6MW3211 injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: up to 24 months
Objective response rate
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

June 27, 2022

First Submitted That Met QC Criteria

June 27, 2022

First Posted (Actual)

June 30, 2022

Study Record Updates

Last Update Posted (Actual)

August 17, 2022

Last Update Submitted That Met QC Criteria

August 14, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6MW3211-2022-CP202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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